(28 days)
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Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML terms or functionalities.
No
The device is a diagnostic tool that measures blood pressure and heart rate; it does not treat or alleviate a medical condition.
Yes
The device measures blood pressure and heart rate, which are physiological parameters used to diagnose health conditions.
No
The description explicitly states the device "Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method" and that "All values can be read out in one LCD panel." This indicates the presence of hardware components (oscillometric sensor, LCD panel) necessary for measurement and display, making it a hardware device with likely embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states the device "Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method." This is a direct measurement of physiological parameters from the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for "adult patients with arm circumference between 24cm-44cm" for measuring blood pressure and heart rate. This aligns with a non-invasive physiological monitoring device.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.
The intended for use of this over-the-counter device is for adult patients with arm circumference between 24cm-44cm (approx. 9.4" to 17.5").
Product codes
DXN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Arm
Indicated Patient Age Range
adult patients
Intended User / Care Setting
over-the-counter device
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Public Health Service
APR - 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Health and Life Co, Ltd. c/o Mr. Paul Hung Manager, Regulation Department 9F, NO. 186, Jian Yi Road Chung Ho City, Taipei Hsien (235) Taiwan R.O.C.
Re: K050587
R020507
Trade Name: H&L Full Automatic (NIBP) Blood Pressure Monitor (HL888KM, HL888DM) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: March 29, 2005 Received: March 31, 2005
Dear Mr. Hung:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bected by ready for the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatives to trg.
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1977, in accordance with the provisions of the Federal Food, Drug, de necs that have been receive approval of a premarket approval application (PMA). and Costicule recry recry that as novice, subject to the general controls provisions of the Act. The I ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provisions of wactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassified (600 a0070). Existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our cements concerning your device in the Federal Register.
1
Page 2 -- Mr. Paul Hung
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe actived that I Dr over device complies with other requirements of the Act that I Dr Has Intact a avoid regulations administered by other Federal agencies. You must or any I catal the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Not 310 cart 801); good manufacturing practice requirements as set CI It Far 6077; adomig (Dr CFR egulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control po begin marketing your device as described in your Section 510(k) rms letter will and my your e FDA finding of substantial equivalence of your device to a legally premainst notification - results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific administrat (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Court County of Court (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormation on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
B. Zimmerman for
Bram D. Zuckerman, M.I Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): _______________________
Device Name: H & L Full Automatic (NIBP) Blood Pressure Monitor, HL888KM, HL888DM
Indications for Use:
Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.
The intended for use of this over-the-counter device is for adult patients with arm circumference between 24cm-44cm (approx. 9.4" to 17.5").
Blumuma
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K0505
Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)